MSN Laboratories Pvt.Ltd R&D Center Walk In Interview 24.01.2020 Walk- In Drive for Regulatory Affairs Dept.in API Division- R&D Center
Walk- In
Drive for Regulatory Affairs Dept.in API
Division- R&D Center.
Should have
minimum of 2 to 8 years of experience in API Regulatory Affairs
Job Title:
Executive / Senior Executive Experience: 2 to 8 years in API RA field
Education: B
Pharma / M Pharma / MSc
Department:
Regulatory Affairs
Job Title:
Executive / Senior Executive Experience: 1 to 8 years in API RA field
Education: M Sc
Department:
Regulatory Affairs
Job Profile:
1. Collecting
and reviewing the documents received from various departments R&D,
AR&D, QA, QC and Production etc at each and every stage of manufacturing of
drug substances to minimize the errors at the time of submission to regulatory
agencies.
2. Hands on
experience on the preparation of DMFs and their registration processes in the
major regulatory regions [US, Canada, Europe etc]..
3. Hands on
experience on preparation of drug master files, Applicants Parts, Tech Pack,
life cycle management [updates and amendments] and drafting of response to
deficiencies and customer DMF review comments for all global regions.
4. Should
have hands on experience on eCTD regulatory submission tools.
5. Should
have knowledge on the requirements to respond to the deficiencies.
6.
Participation in the cross functional team meetings and providing regulatory
inputs to the Product Development Teams.
Job Title:
Junior Manager / Assistant Manager Experience: 6 to 10 years in API RA field
Education: M.Sc
Department:
Regulatory Affairs
Job Profile:
1. Good
scientific conceptual background to the level to evaluate the processes and
procedures in the area of Quality, R&D, AR&D and Production.
2. Manageable
communication in English [should be able to manage regulatory and scientific
discussions in the internal and external meetings and one to one interactions
within the organization and with customers]
3. Manageable
knowledge on the regulatory and quality guidelines from various regulatory
agencies ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
4. Thorough
knowledge and hands on experience on the DMF registration and marketing
authorization application systems in the major regulatory regions [US, Canada,
Europe etc]..
5. Hands on
experience on preparation of drug master files, life cycle management and
drafting of response to deficiencies and customer DMF review comments for all
global regions.
6. Should
have knowledge on product developmental and the quality systems to ensure the
regulatory compliance.
7. Should
have hands on experience on eCTD regulatory submission tools.
8. Conducting
meetings for the deficiencies received from various regulatory agencies and
should have knowledge on the requirements to respond to the deficiencies.
Ensuring that the accurate and adequate responses are sent to the authorities
within the timelines defined by agencies.
9. Thorough
review and ensuring that the regulatory submissions are adequate and error free
with minimum open issues and closing of open issues before filing or before the
receipt of deficiencies.
10.
Participation in the cross functional team meetings and providing regulatory
inputs to the Product Development Teams.
11. Reviewing
the documents received from various departments R&D, AR&D, QA, QC and
Production etc at each and every stage of manufacturing of drug substances to
minimize the errors at the time of submission to regulatory agencies.
12. Review
and assessment of change controls and providing guidance to the team on
proposed changes.
13. Ensuring
that the regulatory databases are properly maintained and updated on time to
time for each regulatory activity.
Drug
Regulatory Affairs API RA Dept.
Exp : 2 to 15
Years
Position:
Junior Executive / Executive /Senior Executive / Junior Manager / Asst Manager
/ Deputy Manager / Manager
Date of
Interview : 24.01.2020 ( Friday )
Interview
Time : 9.00 AM to 1.00 PM
Venue Details
:
MSN
Laboratories Pvt.Ltd.,
R&D
Center, Pashamylaram
Ph No :
+91-8452304799/4899
040-30438786
Work Location
: MSN LS II & R&D Center
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